Search Filters

Search Results

Found 6 results

510(k) Data Aggregation

    K Number
    K102479
    Device Name
    ALARA T210 COMPUTED RADIOGRAPHY SYSTEM
    Manufacturer
    Date Cleared
    2011-06-02

    (276 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALARA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Alara T210 Computed Radiography System is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic filmscreen systems in all general-purpose diagnostic procedures. The T210 is not indicated for use in mammography.
    Device Description
    The Alara T210 is a desktop Computed Radiography (CR) system designed to generate digital x-ray images by reading photostimulable phosphor imaging plates exposed using standard x-ray systems and techniques. The system consists of a CR read or iposeing plates, and cassettes. A computer workstation and OC Acquisition software, will be optionally provided by either Alara or the distribution channel.
    Ask a Question

    Ask a specific question about this device

    K Number
    K071682
    Device Name
    CRYSTALVIEW T-SERIES COMPUTED RADIOGRAPHY SYSTEM, MODELS T110 (WITH ERASER) AND T100 (WITHOUT ERASER)
    Manufacturer
    Date Cleared
    2007-08-15

    (57 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALARA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CRystalView T-Series is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The CRystalView T-Series is not indicated for use in mammography.
    Device Description
    The CRystal View T-Series System is an electrostatic X-ray imaging system that employs storage phosphor plates in place of conventional X-ray film for radiographic imaging applications. The system provides image data that must then be viewed with an external computer and appropriate software. The CRystal View T-Series System is comprised of the following functional components: Reusable storage phosphor plates, multiple sizes; Plate carousels, corresponding to reusable storage phosphor plate size; The CRystal View T-Series Scanner, an image reader /digitizer. The CRystal View T-Series Scanner / Communications Interface, USB 2.0; Optional Integrated phosphor plate eraser; CRystal View T-Series control software and a user or distribution channel-supplied computer system. Image data is sent via a dedicated connection from the CRystalView T-Series Scanner to the computer system, where it is processed and displayed for review.
    Ask a Question

    Ask a specific question about this device

    K Number
    K062390
    Device Name
    CRYSTALVIEW R200
    Manufacturer
    Date Cleared
    2006-09-18

    (33 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALARA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CRystalView R200 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.
    Device Description
    The Alara CRystalView® R200 is a desktop Computed Radiography (CR) system designed to generate digital x-ray images by reading photostimulable phosphor image plates exposed using standard X-ray systems and techniques. The system consists of a CR Reader, a OC Workstation with software, cassettes, and image plates. Image data is sent via a dedicated connection from the Reader to the CRystalView R200 QC Workstation, where it is processed and displayed for review. The system outputs images and patient information to a PACS using the standard DICOM 3.0 protocol. The fully configured CRystalView R200 System includes acquisition console software and post-processing image enhancement software. A reseller may alternatively provide these two software components or appropriately cleared equivalents, as well as the QC Workstation hardware. The modification reported in this submission replaces the integrated third-party image enhancement software with image enhancement software developed by Alara.
    Ask a Question

    Ask a specific question about this device

    K Number
    K061538
    Device Name
    ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200
    Manufacturer
    Date Cleared
    2006-06-30

    (28 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALARA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CRystalView R200 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.
    Device Description
    The Alara CRystalView® R200 is a desktop Computed Radiography (CR) system designed to generate digital x-ray images by reading photostimulable phosphor image plates exposed using standard X-ray systems and techniques. The system consists of a CR Reader, a QC Workstation with software, cassettes, and image plates. Image data is sent via a dedicated connection from the Reader to the CRystalView R200 OC Workstation, where it is processed and displayed for review. The system outputs images and patient information to a PACS using the standard DICOM 3.0 protocol. The fully configured CRystalView R200 System includes acquisition console software and postprocessing image enhancement software. A reseller may alternatively provide these two software components or appropriately cleared equivalents, as well as the QC Workstation hardware.
    Ask a Question

    Ask a specific question about this device

    K Number
    K032210
    Device Name
    ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM
    Manufacturer
    Date Cleared
    2003-10-02

    (73 days)

    Product Code
    Regulation Number
    892.1680
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALARA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CRystalView is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures.
    Device Description
    The Alara CRystalView™ is a Desktop Computed Radiography (CR) System designed to generate digital x-ray images by scanning photo-stimulable storage phosphor imaging plates exposed using standard X-ray systems and techniques. The system consists of a CR Reader, a OC workstation with software, cassettes, and imaging plates. Image data is sent via a dedicated connection from the Reader to the CRystalView QC Workstation, where it is processed and displayed for review. The system outputs images and patient information to a PACS using the standard DICOM 3.0 protocol. The fully configured CRystalView System includes acquisition console software and post-processing image enhancement software. A reseller may alternatively provide these two software components or appropriately cleared equivalents, as well as the QC Workstation hardware.
    Ask a Question

    Ask a specific question about this device

    K Number
    K000162
    Device Name
    METRISCAN BONE DENSITY SYSTEM
    Manufacturer
    Date Cleared
    2000-05-12

    (114 days)

    Product Code
    Regulation Number
    892.1170
    Why did this record match?
    Applicant Name (Manufacturer) :

    ALARA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Device Description
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1